A recently published article in The Wall Street Journal proposes several changes to the FDA approval process. However, at a time when there should be more emphasis on accelerating biosimilar approval, this proposal very well could spell trouble for biosimilars.
The Brexit referendum has resulted in instability and uncertainty for many aspects of British society, including the pharmaceutical industry. As we discussed in Part 1 of this two-part article, life sciences funding and the common market are at risk, and with it billions of dollars in research funding and imports/exports. In this article, we will explore the UK’s future relationship with the EU after exit, which will affect many facets of the worldwide pharmaceutical industry, from marketing authorization to global pricing trends.
PhRMA is facing a controversial, potentially industry-altering decision. The generics king Teva has requested to become a member of the trade organization that traditionally represents “innovators”. Could this move redefine the industry's perception of "innovation"?
On June 23, 2016, the voters of the United Kingdom voted to leave the European Union in an advisory referendum colloquially referred to as the “Brexit” (British exit) vote. The aftermath of the vote has been chaotic — from financial troubles that have seen the British economy and currency plummet, to political bedlam that has led to a number of political casualties, including the Prime Minister and his heir apparent. While analysts, journalists, and the public all discuss the impact of Brexit on the UK and the path forward, few realize the implications that the vote will have on healthcare, and the pharmaceutical industry in particular.
Not only are there some fascinating parallels between the fledging biosimilar and lab-grown diamond industries, but there are also some lessons biosimilar makers can take away from the development and commercialization of lab-grown diamonds.
The FDA publishes data on Form 483 inspection observations and warning letters issued by the Center for Drug Evaluation and Research (CDER) during the previous fiscal year. By analyzing this annual data pharmaceutical and biopharmaceutical manufacturers can gain a clearer picture of FDA enforcement trends and their potential impact on business.
In his presentation at the 2016 World Biosimilar Congress USA, Elliot Morales, senior director of regulatory affairs, at Dr. Reddy’s Laboratories, discussed the regulatory landscape for companies planning to introduce biosimilars in emerging markets. There were six points worth noting from this presentation which can alter the shape and timeline of a global development program and market approval.
The continuing efforts by biologic and pharmaceutical manufacturers to join the FDA in improving product quality, reducing inspection costs, increasing the effectiveness of product monitoring, and streamlining reporting requirements have crossed the Rubicon of mere theorizing, discussion, and contemplation into firm and proactive steps.
There are several questions biosimilar makers should ask before immediately launching into the “patent dance.”
The emerging markets have been making strides in developing pathways for the approvals of biosimilars. However, there are several considerations companies need to keep in mind when putting together a dossier for market approval in Russia, Colombia, Peru, and Malaysia.
In this e-book, you’ll find insight and advice from some of the top experts at Phillips-Medisize who have experience navigating the intertwined pathways of the drug and medtech industries that ultimately bring combination products to market.
With the explosion of the biologics market, which now accounts for an estimated 20% of all pharmaceutical sales, the industry has entered a new era of drug development. This growth — 10 percent to 15 percent each year — is being driven by monoclonal antibodies, which are anticipated to have worldwide sales of nearly $125 billion by 2021. However, this burgeoning market comes with some considerable challenges for drug manufacturers, due to the fragile nature and instability of these large, complex molecules.
It has only been short time – five years or so -- since immunotherapy first broke into the headlines following the approval of ipilimumab and later of nivolumab as monotherapy for melanoma and squamous lung cancer, respectively. Since then, as immunotherapies continue to show promise for other cancers, attempts to evaluate optimal tissue biomarkers to identify patients likely to benefit have also been an active area of research.
Although I’ve rarely traveled to shows since we launched Life Science Leader in 2009, I’m not unfamiliar with fulfilling this duty as an editor; I did it for six years prior to focusing exclusively on LSL. Still, there was one element of World Biosimilar Congress that seemed foreign to me — the role of the chairperson Richard DiCicco.
Successful prototyping begins with mechanical design that will operate properly when assembled and will be scalable for volume manufacturing. A working prototype can be a smooth progression if you employ the right resources and processes.
Biosimilar Development is dedicated to presenting technical information, thought leadership, and commentary for the biosimilar development and manufacturing community. On this site, users will find exclusive and actionable content on the industry trends and challenges affecting the emerging biosimilars market. Browse our articles, case studies, and white papers on topics related to biosimilar development, manufacturing, quality, distribution, FDA guidance, BPCIA, global markets, government regulations, and intellectual property.
Biosimilar Development is part of the Life Science Connect media group, which strives to facilitate connections and foster collaborations in pharmaceutical development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.